single dose clamp study to compare concentration/time profile and metabolic activity profile of 2 new formulations of insulin glargine with lantus

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: to compare the pharmacokinetic (pk) characteristics of single doses of insulin glargine given as u200 and u500 with those of a single dose (sd) of lantus® u100 in a euglycemic clamp setting in subjects with type 1 diabetes. secondary objectives: to compare the metabolic activity characteristics of single doses of insulin glargine given as u200 and u500 with those of a single dose of lantus® u100 in a euglycemic clamp setting in subjects with type 1 diabetes. to assess the safety and tolerability of single doses of u200, u500 and lantus® u100 in subjects with type 1 diabetes.

total study duration for each subject is between 3.5 and 12 weeks. two overnight stays at the unit in each of 3 treatment periods.

Eligibility criteria:
inclusion criteria: * male or female subjects, between 18 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the american diabetes association. * total insulin dose \<1.2 u/kg/day. * minimum usual basal insulin dose ≥0.2 u/kg/day. * body weight between 50.0 kg and 110.0 kg, body mass index between 18.5 and 30.0 kg/m2 inclusive. * fasting negative serum c-peptide (\<0.3 nmol/l). * glycohemoglobin (hba1c) ≤75 mmol/mol (≤9.0%). * stable insulin regimen for at least 2 months prior to inclusion in study. * certified as otherwise healthy for type 1 diabetes mellitus patient. * women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status. * having given written informed consent prior to undertaking any study-related procedure. exclusion criteria: * more than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months. * frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month). * presence or history of a drug allergy or clinically significant allergic disease according to the investigator's judgment. * presence or history of drug or alcohol abuse (alcohol consumption \>40 grams / day). * smoking more than 5 cigarettes or equivalent per day, unable to refrain from smoking. * any medication (including st john's wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever the longest and regular use of any medication in the last month before study start with the exception of insulin products, thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days; any biologics (antibody or its derivatives) given within 4 months before randomization. * known hypersensitivity to insulin glargine or excipients of the study drug. * any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.